Pomalidomide (Pomalyst) alone has shown limited efficacy in relapsed multiple myeloma, but synergistic effects have been noted when it is combined with dexamethasone. In a phase III trial (MM-003) reported in The Lancet Oncology, Jesus San Miguel, MD, of Universidad de Salamanca, and colleagues found that the combination of pomalidomide plus low-dose dexamethasone was associated with significantly prolonged progression-free survival and overall survival compared with high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

Study Details

In this multinational open-label trial, 455 patients with refractory or relapsed and refractory multiple myeloma were randomly assigned 2:1 to receive 28-day cycles of oral pomalidomide (4 mg/d on days 1–21) plus low-dose dexamethasone (40 mg/d on days 1, 8, 15, and 22) (n = 302) or high-dose dexamethasone (40 mg/d on days 1–4, 9–12, and 17–20) (n = 153) until disease progression or unacceptable toxicity. For patients to be eligible, they had to have received at least two previous treatments of bortezomib (Velcade) and lenalidomide (Revlimid) that failed. The primary endpoint was progression-free survival.

In the pomalidomide plus low-dose dexamethasone group, 67% of patients required pomalidomide dose interruptions and 27% required pomalidomide dose reductions. In the high-dose dexamethasone group, 28% had dose interruptions and 32% had dose reductions. Discontinuation of treatment due to treatment-related adverse events occurred in 4% vs 6% of patients. Treatment-related adverse events led to death in 4% and 5% of patients.

The investigators concluded: “Studies of different combinations including pomalidomide in patients with refractory or relapsed and refractory multiple myeloma have shown promising results, and the enhanced effects with pomalidomide combinations should be further investigated. Based on these findings and the results of previous trials, pomalidomide plus low-dose dexamethasone could be a new treatment option for patients with advanced refractory or relapsed and refractory multiple myeloma.”

The study was funded by Celgene Corporation.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.